Spacer Assembly for Drug Delivery System

ABSTRACT

A drug delivery system for injecting a medicament includes a container including a closure and a stopper configured to move within the container from a pre-use position to a post-use position. The system includes a drive assembly configured to move the stopper between first and second positions, and a spacer assembly engaged with the stopper configured to be engaged by the drive assembly. The spacer assembly includes a first spacer portion received within the stopper, a second spacer portion spaced from the first spacer portion, an inner plunger, and a spacer shuttle received by the inner plunger. The inner plunger, the spacer shuttle, and the second portion are configured to move relative to the stopper, where movement of the second spacer portion is restricted by the spacer shuttle, movement of the spacer shuttle is restricted by the inner plunger, and movement of the inner plunger is restricted by the stopper.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.15/616,183, filed Jun. 7, 2017, which claims priority to U.S.Provisional Application Ser. No. 62/347,911, filed Jun. 9, 2016, whichis hereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION Field of the Disclosure

The present disclosure relates generally to an injector device andmethod for delivering a fluid into the body of a patient by injection.

Description of the Related Art

Various types of automatic injection devices have been developed toallow drug solutions and other liquid therapeutic preparations to beadministered by untrained personnel or to be self-injected. Generally,these devices include a reservoir that is pre-filled with the liquidtherapeutic preparation, and some type of automatic needle-injectionmechanism that can be triggered by the user. When the volume of fluid ordrug to be administered is generally below a certain volume, such as 1mL, an auto-injector is typically used, which typically has an injectiontime of about 10 to 15 seconds. When the volume of fluid or drug to beadministered is above 1 mL, the injection time generally becomes longerresulting in difficulties for the patient to maintain contact betweenthe device and the target area of the patient's skin. Further, as thevolume of drug to be administered becomes larger, increasing the timeperiod for injection becomes desirable. The traditional method for adrug to be injected slowly into a patient is to initiate an IV andinject the drug into the patient's body slowly. Such a procedure istypically performed in a hospital or outpatient setting.

Certain devices allow for self-injection in a home setting and arecapable of gradually injecting a liquid therapeutic preparation into theskin of a patient. In some cases, these devices are small enough (bothin height and in overall size) to allow them to be “worn” by a patientwhile the liquid therapeutic preparation is being infused into thepatient. These devices typically include a pump or other type ofdischarge mechanism to force the liquid therapeutic preparation to flowout of a reservoir and into the injection needle. Such devices alsotypically include a valve or flow control mechanism to cause the liquidtherapeutic preparation to begin to flow at the proper time and atriggering mechanism to initiate the injection.

SUMMARY OF THE INVENTION

In one aspect, a drug delivery system for injecting a medicamentincludes a container configured to receive a medicament including astopper and a closure, where the stopper is configured to move withinthe container from a pre-use position to a post-use position. The systemincludes a drive assembly configured to move the stopper between a firstposition and a second position, and a spacer assembly engaged with thestopper of the container and configured to be engaged by the driveassembly. The spacer assembly includes a first spacer portion receivedwithin the stopper, a second spacer portion spaced from the first spacerportion a predetermined distance, an inner plunger, and a spacer shuttlereceived by the inner plunger. The inner plunger, the spacer shuttle,and the second portion are configured to move relative to the stopper,where movement of the second spacer portion is restricted by the spacershuttle, movement of the spacer shuttle is restricted by the innerplunger, and movement of the inner plunger is restricted by the stopper.

The inner plunger may have a first position and a second position spacedaxially from the first position, with the spacer shuttle restricted fromaxial movement when the inner plunger is in the first position andmoveable relative to the stopper when the inner plunger is in the secondposition. The second spacer portion may be restricted from axialmovement via the spacer shuttle when the inner plunger is in the firstposition and moveable relative to the stopper when the inner plunger isin the second position. The stopper may have a closed first end and asecond open end, with the closed first end of the stopper axiallymoveable relative to the container between a use position where theclosed first end of the stopper is engaged with the inner plunger and anend-of-dose position where the closed first end of the stopper is spacedfrom the inner plunger, and where inner plunger is free to move from thefirst position to the second position when the stopper is in theend-of-dose position. The stopper may be configured to move between theuse position and the end-of-dose position based on engagement with amedicament received within the container.

The stopper may have a closed first end and a second open end, with theclosed first end of the stopper is axially moveable relative to thecontainer between a use position where the closed first end of thestopper is engaged with the inner plunger and an end-of-dose positionwhere the closed first end of the stopper is spaced from the innerplunger, and where the inner plunger is free to move from the firstposition to the second position when the stopper is in the end-of-doseposition. The stopper may be configured to move between the use positionand the end-of-dose position based on engagement with a medicamentreceived within the container. Movement of the second portion of thespacer assembly the predetermined distance may be configured to causethe drive assembly to trigger retraction of a needle. The spacer shuttlemay be rotatable relative to the inner plunger, and where axialdisplacement of the second portion of the spacer assembly is configuredto cause rotation of the spacer shuttle. The second portion of thespacer assembly may define an access opening configured to allow directengagement of the first spacer portion of the spacer assembly.

In a further aspect, a spacer assembly for a drug delivery system forinjecting a medicament includes a first spacer portion configured to bereceived by a stopper, a second spacer portion spaced from the firstspacer portion a predetermined distance, an inner plunger, and a spacershuttle received by the inner plunger, where the inner plunger, thespacer shuttle, and the second portion of the spacer are configured tomove relative to the first spacer portion. Movement of the second spacerportion is restricted by the spacer shuttle, and movement of the spacershuttle is restricted by the inner plunger.

The inner plunger may have a first position and a second position spacedaxially from the first position, and the spacer shuttle may berestricted from axial movement when the inner plunger is in the firstposition and moveable relative to the stopper when the inner plunger isin the second position. The second spacer portion may be restricted fromaxial movement via the spacer shuttle when the inner plunger is in thefirst position and moveable relative to the stopper when the innerplunger is in the second position. The second portion of the spacerassembly may be free to move toward the first portion of the spacerassembly when the first plunger is in the second position. The spacershuttle may be rotatable relative to the inner plunger, where axialdisplacement of the second portion of the spacer assembly is configuredto cause rotation of the spacer shuttle. The second spacer portion ofthe spacer assembly may define an access opening configured to allowdirect engagement of the first spacer portion of the spacer assembly.The first portion of the spacer assembly and the second portion of thespacer assembly may be secured to each other while allowing relativeaxial movement for the predetermined distance.

In a further aspect, a drug delivery system for injecting a medicamentincludes a container configured to receive a medicament including astopper and a closure, with the stopper configured to move within thecontainer from a pre-use position to a post-use position. The systemalso includes a spacer assembly comprising a fixed spacer and anadjustable spacer, with the fixed spacer received by the stopper. Theadjustable spacer is secured to the fixed spacer and moveable relativeto the spacer assembly a predetermined axial distance.

The adjustable spacer may only be moveable in a first axial directionrelative to the fixed spacer. The spacer assembly may include a ratchetarrangement with one of the fixed spacer and the adjustable spacerincluding a plurality of detents and the other of the fixed spacer andthe adjustable spacer including a spring detent arm, and where rotationof the adjustable spacer relative to the fixed spacer in a firstrotational direction moves the adjustable spacer the predetermined axialdistance. The system may also include a shim configured to be secured tothe adjustable spacer.

In a further aspect, a drug delivery system for injecting a medicamentincludes a container configured to receive a medicament, with thecontainer including a stopper configured to move within the containerand a closure, and a drive assembly including: a plunger memberconfigured to move the stopper within the container, with the plungermember having a first position and a second position axially spaced fromthe first position, a biasing member configured to move the plungermember from the first position to the second position, and a plungeractuation member moveable relative to the plunger member. The plungeractuation member having a first position where the plunger member isaxially fixed relative to the plunger actuation member and a secondposition where the plunger member is axially moveable relative to theplunger actuation member. The system also includes a needle actuatorassembly including a needle configured to be placed in fluidcommunication with the container, with the needle moveable from a firstposition and a second position spaced from the first position, arestriction member configured to restrict movement of the needleactuator assembly, and a spacer assembly comprising a fixed spacer andan adjustable spacer, with the fixed spacer received by the stopper. Theadjustable spacer is secured to the fixed spacer and moveable relativeto the spacer assembly a predetermined axial distance.

The restriction member may be configured to engage a rear portion of thecontainer.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a drug delivery system according to oneaspect of the present invention.

FIG. 2 is a perspective, cross-sectional view of the drug deliverysystem of FIG. 1 according to one aspect of the present invention.

FIG. 3 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention.

FIG. 4 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in a pre-use position.

FIG. 5 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a pre-use position.

FIG. 6 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a pre-use position.

FIG. 7 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in an initial actuationposition.

FIG. 8 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in an initial actuation position.

FIG. 9 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in an initial actuation position.

FIG. 10 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in a use position.

FIG. 11 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a use position.

FIG. 12 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a use position.

FIG. 13 is a top view of the drug delivery system of FIG. 1 according toone aspect of the present invention, showing a top portion of thehousing removed and the drug delivery system in a post-use position.

FIG. 14 is a top, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a post-use position.

FIG. 15 is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing thedrug delivery system in a post-use position.

FIG. 15A is a front, cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing a padwith the drug delivery system in a pre-use position.

FIG. 15B is a perspective, cross-sectional view of the drug deliverysystem of FIG. 1 according to one aspect of the present invention,showing a pad with the drug delivery system in a pre-use position.

FIG. 15C is a perspective, cross-sectional view of the drug deliverysystem of FIG. 1 according to one aspect of the present invention,showing a pad with the drug delivery system in a pre-use position.

FIG. 16 is a partial cross-sectional view of the drug delivery system ofFIG. 1 according to one aspect of the present invention, showing a valveassembly.

FIG. 17 is a perspective view of a drive assembly for a drug deliverysystem according to one aspect of the present invention.

FIG. 18 is a cross-sectional view of the drive assembly of FIG. 17according to one aspect of the present invention, showing a pre-useposition of the drive assembly.

FIG. 19 is a cross-sectional view of the drive assembly of FIG. 17according to one aspect of the present invention, showing a use positionof the drive assembly.

FIG. 20 is a cross-sectional view of the drive assembly of FIG. 17according to one aspect of the present invention, showing a post-useposition of the drive assembly.

FIG. 21 is a perspective view of a plunger actuation member of the driveassembly of FIG. 17 according to one aspect of the present invention.

FIG. 22 is a perspective view of a first plunger member of the driveassembly of FIG. 17 according to one aspect of the present invention.

FIG. 23 is a perspective view of a plunger actuation member and firstplunger member of the drive assembly of FIG. 17 according to one aspectof the present invention, showing the plunger actuation member engagedwith the first plunger member.

FIG. 24 is a perspective view of a plunger actuation member and firstplunger member of the drive assembly of FIG. 17 according to one aspectof the present invention, showing the plunger actuation memberdisengaged from the first plunger member.

FIG. 25 is a perspective view of a plunger actuation member and firstplunger member of the drive assembly of FIG. 17 according to one aspectof the present invention, showing the plunger actuation memberdisengaged from and axially displaced relative to the first plungermember.

FIG. 26 is a front view of a first plunger member and a second plungermember of the drive assembly of FIG. 17 according to one aspect of thepresent invention.

FIG. 27 is a top view of a drive assembly for a drug delivery systemaccording to a further aspect of the present invention.

FIG. 28 is a perspective view of the drive assembly of FIG. 27 accordingto one aspect of the present invention.

FIG. 29 is a cross-sectional view of the drive assembly of FIG. 27according to one aspect of the present invention, showing a pre-useposition of the drive assembly.

FIG. 30 is a perspective view of the drive assembly of FIG. 27 accordingto one aspect of the present invention, showing the drive assemblyreceived by a bottom portion of a housing.

FIG. 31 is a perspective view of the housing of FIG. 30 according to oneaspect of the present invention.

FIG. 32 is a top view of the drive assembly of FIG. 27 according to oneaspect of the present invention, showing engagement of the driveassembly with a portion of a needle actuator in an initial actuationposition of the drive assembly.

FIG. 33 is an enlarged perspective view of the drive assembly of FIG. 27according to one aspect of the present invention, showing engagement ofthe drive assembly with a portion of a needle actuator in an initialactuation position of the drive assembly.

FIG. 34 is a front view of a needle actuator assembly according to oneaspect of the present invention.

FIG. 35 is a left side perspective view of a needle shuttle of theneedle actuator assembly of FIG. 34 according to one aspect of thepresent invention.

FIG. 36 is a right side perspective view of a needle shuttle of theneedle actuator assembly of FIG. 34 according to one aspect of thepresent invention.

FIG. 37A is a front view of the needle actuator assembly of FIG. 34according to one aspect of the present invention, showing the needleactuator assembly in a pre-use position.

FIG. 37B is a front view of the needle actuator assembly of FIG. 34according to one aspect of the present invention, showing the needleactuator assembly in a use position.

FIG. 37C is a front view of the needle actuator assembly of FIG. 34according to one aspect of the present invention, showing the needleactuator assembly in an initial post-use position.

FIG. 37D is a front view of the needle actuator assembly of FIG. 34according to one aspect of the present invention, showing the needleactuator assembly in a post-use position.

FIG. 38A is a perspective view of the needle actuator assembly of FIG.34 according to one aspect of the present invention, showing the needleactuator assembly in a use position.

FIG. 38B is a perspective view of the needle actuator assembly of FIG.34 according to one aspect of the present invention, showing the needleactuator assembly in an initial post-use position.

FIG. 39 is a perspective view of an actuator button and the needleactuator assembly of FIG. 34 according to one aspect of the presentinvention, showing the needle actuator assembly in an initial post-useposition.

FIG. 40A is a cross-sectional view of an actuator button and the needleactuator assembly of FIG. 34 according to one aspect of the presentinvention, showing the needle actuator assembly in an initial post-useposition.

FIG. 40B is a perspective view of an actuator button and the needleactuator assembly of FIG. 34 according to one aspect of the presentinvention, showing the needle actuator assembly in a post-use position.

FIG. 41 is a perspective view of a drive assembly for a drug deliverysystem according to a further aspect of the present invention.

FIG. 42 is a perspective view of the drive assembly of FIG. 41 accordingto one aspect of the present invention, showing a top portion of ahousing removed.

FIG. 43 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention.

FIG. 44 is a perspective view of the drive assembly of FIG. 41 accordingto one aspect of the present invention.

FIG. 45 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a pre-use position.

FIG. 46 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a pre-use position.

FIG. 47 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in a pre-useposition.

FIG. 48 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in aninitial actuation position.

FIG. 49 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in aninitial actuation position.

FIG. 50 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly an initialactuation position.

FIG. 51 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in a useposition.

FIG. 52 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in a useposition.

FIG. 53 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a use position.

FIG. 54 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in a useposition.

FIG. 55 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a use position.

FIG. 56 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a use position.

FIG. 57 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in a useposition.

FIG. 58 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in aninitial post-use position.

FIG. 59 is a perspective view of the drive assembly of FIG. 41 accordingto one aspect of the present invention, showing the drive assembly in aninitial post-use position.

FIG. 60 is a top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in apost-use position.

FIG. 61 top view of the drive assembly of FIG. 41 according to oneaspect of the present invention, showing the drive assembly in apost-use position.

FIG. 62 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a pre-use position.

FIG. 63 is a cross-sectional view of the drive assembly of FIG. 41according to one aspect of the present invention, showing the driveassembly in a use position.

FIG. 64 is a perspective view of a drive assembly according to a furtheraspect of the present invention.

FIG. 65A is a front view of a needle actuator assembly according to oneaspect of the present invention, showing the needle actuator assembly ina use position.

FIG. 65B is a front view of the needle actuator assembly of FIG. 65Aaccording to one aspect of the present invention, showing the needleactuator assembly in a use position.

FIG. 65C is a front view of the needle actuator assembly of FIG. 65Aaccording to one aspect of the present invention, showing the needleactuator assembly in an initial post-use position.

FIG. 65D is a front view of the needle actuator assembly of FIG. 65Aaccording to one aspect of the present invention, showing the needleactuator assembly in a post-use position.

FIG. 65E is a front view of the needle actuator assembly of FIG. 65Aaccording to one aspect of the present invention, showing the needleactuator assembly in a pre-use position.

FIG. 65F is a cross-sectional view of the needle actuator assembly ofFIG. 65A according to one aspect of the present invention, showing theneedle actuator assembly in a pre-use position.

FIG. 65G is a front view of the needle actuator assembly of FIG. 65Aaccording to one aspect of the present invention, showing the needleactuator assembly in a pre-use position with a button actuator axiallydisplaced.

FIG. 65H is a cross-sectional view of the needle actuator assembly ofFIG. 65A according to one aspect of the present invention, showing theneedle actuator assembly in a pre-use position with a button actuatoraxially displaced.

FIG. 66 is a perspective view of a button spring of the needle actuatorassembly of FIG. 65A according to one aspect of the present invention.

FIG. 67 is a perspective view of an actuator button of the needleactuator assembly of FIG. 65A according to one aspect of the presentinvention.

FIG. 68 is a cross-sectional view of a button spring and actuator buttonof the needle actuator assembly of FIG. 65A according to one aspect ofthe present invention.

FIG. 68A is a perspective view of an actuator button of the needleactuator assembly of FIG. 65A according to a further aspect of thepresent invention.

FIG. 68B is a bottom view of an actuator button of the needle actuatorassembly of FIG. 65A according to a further aspect of the presentinvention.

FIG. 68C is a front view of an actuator button of the needle actuatorassembly of FIG. 65A according to a further aspect of the presentinvention.

FIG. 68D is a top view of an actuator button of the needle actuatorassembly of FIG. 65A according to a further aspect of the presentinvention, showing the actuator button in a pre-use position

FIG. 68E is a front view of an actuator button of the needle actuatorassembly of FIG. 65A according to a further aspect of the presentinvention, showing the actuator button in a pre-use position.

FIG. 68F is a top view of an actuator button of the needle actuatorassembly of FIG. 65A according to a further aspect of the presentinvention, showing the actuator button in a use position.

FIG. 68G is a front view of an actuator button of the needle actuatorassembly of FIG. 65A according to a further aspect of the presentinvention, showing the actuator button in a use position.

FIG. 69 is a top view of an actuator button of the needle actuatorassembly of FIG. 65A according to one aspect of the present invention.

FIG. 70A is a schematic view of a drive assembly according to one aspectof the present invention, showing the drive assembly in a pre-useposition.

FIG. 70B is a schematic view of the drive assembly of FIG. 70A accordingto one aspect of the present invention, showing the drive assembly in ause position.

FIG. 70C is a schematic view of the drive assembly of FIG. 70A accordingto one aspect of the present invention, showing the drive assembly in ause position.

FIG. 70D is a schematic view of the drive assembly of FIG. 70A accordingto one aspect of the present invention, showing the drive assembly in ause position.

FIG. 70E is a schematic view of the drive assembly of FIG. 70A accordingto one aspect of the present invention, showing the drive assembly in ause position.

FIG. 70F is a schematic view of the drive assembly of FIG. 70A accordingto one aspect of the present invention, showing the drive assembly in apost-use position.

FIG. 70G is a schematic view of the drive assembly of FIG. 70A accordingto one aspect of the present invention, showing the drive assembly in apost-use position.

FIG. 71 is a perspective view of a spacer assembly for a drug deliverysystem according to one aspect of the present invention, showing anassembled, pre-use position of the spacer assembly.

FIG. 72 is a perspective view of the spacer assembly of FIG. 71according to one aspect of the present invention, showing a use positionof the spacer assembly.

FIG. 73 is a perspective view of the spacer assembly of FIG. 71according to one aspect of the present invention, showing an initialpost-use position of the spacer assembly.

FIG. 74 is a perspective view of a restriction member according to oneaspect of the present invention.

FIG. 75 is a front view of a spacer assembly for a drug delivery systemaccording to a further aspect of the present invention.

FIG. 76 is a top view of a spacer assembly for a drug delivery systemaccording to one aspect of the present invention.

FIG. 77 is a perspective view of the spacer assembly of FIG. 76according to one aspect of the present invention.

FIG. 78 is a cross-sectional view of the spacer assembly of FIG. 76according to one aspect of the present invention.

FIG. 79 is a perspective view of a spacer assembly for a drug deliverysystem according to a further aspect of the present invention.

FIG. 80 is a perspective view of a spacer assembly for a drug deliverysystem according to another aspect of the present invention.

FIG. 81A is a cross-sectional view of the spacer assembly of FIG. 80according to one aspect of the present invention, showing a pre-assemblyposition of the spacer assembly.

FIG. 81B is a cross-sectional view of the spacer assembly of FIG. 80according to one aspect of the present invention, showing an assembledposition of the spacer assembly.

FIG. 82 is a perspective view of a drive assembly for a drug deliverysystem according to one aspect of the present invention.

FIG. 83 is a perspective view of the drive assembly of FIG. 82 accordingto one aspect of the present invention, showing a top portion of ahousing removed.

FIG. 84 is a cross-sectional view of the drive assembly of FIG. 82according to one aspect of the present invention, showing a pre-useposition of the drive assembly.

FIG. 85 is an enlarged cross-sectional view of the drive assembly ofFIG. 82 according to one aspect of the present invention, showing apre-use position of the drive assembly.

FIG. 86 is a top view of a biasing member of the drive assembly of FIG.82 according to one aspect of the present invention.

FIG. 87 is a perspective view of the drive assembly of FIG. 82 accordingto one aspect of the present invention, showing a restriction memberengaged with the drive assembly.

FIG. 88 is a perspective view of a drive assembly for a drug deliverysystem according to one aspect of the present invention.

FIG. 89 is a perspective view of the drive assembly of FIG. 88 accordingto one aspect of the present invention, showing a pre-use position ofthe drive assembly.

FIG. 90 is a cross-sectional view of the drive assembly of FIG. 88according to one aspect of the present invention.

FIG. 91 is a perspective view of the drive assembly of FIG. 88 accordingto one aspect of the present invention, showing a post-use position ofthe drive assembly.

FIG. 92 is a cross-sectional view of the drive assembly of FIG. 88according to one aspect of the present invention, showing a pre-useposition of the drive assembly.

FIG. 93 is a front view of the drive assembly of FIG. 88 according toone aspect of the present invention, showing a use position of the driveassembly.

FIG. 94 is a perspective view of a spacer assembly for a drug deliverysystem according to one aspect of the present invention.

FIG. 95 is a front view of the spacer assembly of FIG. 94 according toone aspect of the present invention.

FIG. 96 is a cross-sectional view of the spacer assembly of FIG. 94according to one aspect of the present invention.

FIG. 97 is a perspective view of the spacer assembly of FIG. 94according to one aspect of the present invention, showing a shimremoved.

FIG. 98 is a perspective view of a fixed spacer of the spacer assemblyof FIG. 94 according to one aspect of the present invention.

FIG. 99 is a perspective view of an adjustable spacer of the spacerassembly of FIG. 94 according to one aspect of the present invention.

FIG. 100 is a perspective view of a shim of the spacer assembly of FIG.94 according to one aspect of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary aspects of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

Referring to FIGS. 1-16, a drug delivery system 10 according to oneaspect of the present invention includes a drive assembly 12, acontainer 14, a valve assembly 16, and a needle actuator assembly 18.The drive assembly 12, the container 14, the valve assembly 16, and theneedle actuator assembly 18 are at least partially positioned within ahousing 20. The housing 20 includes a top portion 22 and a bottomportion 24, although other suitable arrangements for the housing 20 maybe utilized. In one aspect, the drug delivery system 10 is an injectordevice configured to be worn or secured to a user and to deliver apredetermined dose of a medicament provided within the container 14 viainjection into the user. The system 10 may be utilized to deliver a“bolus injection” where a medicament is delivered within a set timeperiod. The medicament may be delivered over a time period of up to 45minutes, although other suitable injection amounts and durations may beutilized. A bolus administration or delivery can be carried out withrate controlling or have no specific rate controlling. The system 10 maydeliver the medicament at a fixed pressure to the user with the ratebeing variable. The general operation of the system 10 is describedbelow in reference to FIGS. 1-16 with the specifics of the driveassembly 12, needle actuator assembly 18, and other features of thesystem 10, discussed below in connection with FIGS. 17-93.

Referring again to FIGS. 1-16, the system 10 is configured to operatethrough the engagement of an actuation button 26 by a user, whichresults in a needle 28 of the needle assembly 18 piercing the skin of auser, the actuation of the drive assembly 12 to place the needle 28 influid communication with the container 14 and to expel fluid ormedicament from the container 14, and the withdrawal of the needle 28after injection of the medicament is complete. The general operation ofa drug delivery system is shown and described in InternationalPublication Nos. 2013/155153 and 2014/179774, which are herebyincorporated by reference in their entirety. The housing 20 of thesystem 10 includes an indicator window 30 for viewing an indicatorarrangement 32 configured to provide an indication to a user on thestatus of the system 10 and a container window 31 for viewing thecontainer 14. The indicator window 30 may be a magnifying lens forproviding a clear view of the indicator arrangement 32. The indicatorarrangement 32 moves along with the needle actuator assembly 18 duringuse of the system 10 to indicate a pre-use status, use status, andpost-use status of the system 10. The indicator arrangement 32 providesvisual indicia regarding the status, although other suitable indicia,such an auditory or tactile, may be provided as an alternative oradditional indicia.

Referring to FIGS. 4-6, during a pre-use position of the system 10, thecontainer 14 is spaced from the drive assembly 12 and the valve assembly16 and the needle 28 is in a retracted position. During the initialactuation of the system 10, as shown in FIGS. 7-9, the drive assembly 12engages the container 14 to move the container 14 toward the valveassembly 16, which is configured to pierce a closure 36 of the container14 and place the medicament within the container 14 in fluidcommunication with the needle 28 via a tube (not shown) or othersuitable arrangement. The drive assembly 12 is configured to engage astopper 34 of the container 14, which will initially move the entirecontainer 14 into engagement with the valve assembly 16 due to theincompressibility of the fluid or medicament within the container 14.The initial actuation of the system 10 is caused by engagement of theactuation button 26 by a user, which releases the needle actuatorassembly 18 and the drive assembly 12 as discussed below in more detail.During the initial actuation, the needle 28 is still in the retractedposition and about to move to the extended position to inject the userof the system 10.

During the use position of the system 10, as shown in FIGS. 10-12, theneedle 28 is in the extended position at least partially outside of thehousing 20 with the drive assembly 12 moving the stopper 34 within thecontainer 14 to deliver the medicament from the container 14, throughthe needle 28, and to the user. In the use position, the valve assembly16 has already pierced a closure 36 of the container 14 to place thecontainer 14 in fluid communication with the needle 28, which alsoallows the drive assembly 12 to move the stopper 34 relative to thecontainer 14 since fluid is able to be dispensed from the container 14.At the post-use position of the system 10, shown in FIGS. 13-15, theneedle 28 is in the retracted position and engaged with a pad 38 to sealthe needle 28 and prevent any residual flow of fluid or medicament fromthe container 14. The container 14 and valve assembly 16 may be thecontainer 14 and valve assembly 16 shown and described in InternationalPublication No. WO 2015/081337, which is hereby incorporated byreference in its entirety.

Referring to FIGS. 15A-15C, the pad 38 is biased into the pad as theneedle actuator body 96 moves from the use position to the post-useposition. In particular, the pad 38 is received by a pad arm 122 havinga cam surface 124 that cooperates with a cam track 126 on the bottomportion 24 of the housing 20. The pad arm 122 is connected to the needleactuator body 96 via a torsion bar 128. The cam surface 124 isconfigured to engage the cam track 126 to deflect the pad arm 122downwards thereby allowing the pad 38 to pass beneath the needle 28before being biased upwards into the needle 28. The torsion bar 128allows the pad arm 122 to twist about a pivot of the needle actuatorbody 96. The pad 38 may be press-fit into an opening of the pad arm 122,although other suitable arrangements for securing the pad 38 may beutilized.

Referring to FIGS. 1-33, the drive assembly 12 according to one aspectof the present invention is shown. As discussed above, the driveassembly 12 is configured to move the container 14 to pierce the closure36 of the container 14 and also to move the stopper 34 within thecontainer 14 to dispense fluid or medicament from the container 14. Thedrive assembly 12 shown in FIGS. 17-33 is configured to engage andcooperate with a spacer assembly 40 received by the stopper 34 of thecontainer 14. The spacer assembly 40 includes a spacer 42 and a spacerholder 44. The spacer holder 44 is received by the stopper 34 and thespacer 42 is received by the spacer holder 44. The spacer holder 44includes a first threaded portion 46 that engages a correspondingthreaded portion of the stopper 34, although other suitable arrangementsmay be utilized. The spacer 42 also includes a threaded portion 48 thatengages a corresponding second threaded portion 50 of the spacer holder44 for securing the spacer 42 to the spacer holder 44, although othersuitable arrangements may be utilized. The drive assembly 12 isconfigured to dispense a range of pre-determined fill volumes of thecontainer 14 while maintaining the functional features of the system 10described above, including, but not limited to, retraction of the needle28 after the end of the dose and providing an indication of the statusof the system 10 while also minimizing abrupt engagement of the stopper34 by the drive assembly 12. The drive assembly 12 is configured todispense a plurality of discrete fill volume ranges by utilizing aplurality of sizes of the spacers 42. In one aspect, twelve fill volumeranges and twelve spacer 42 sizes are provided. In one aspect, thelength of the spacer 42 is changed to accommodate different fill volumesin the container 14. Alternatively, a single size spacer 42 may beutilized with a plurality of fill volumes in the container 14accommodated by utilizing a plurality of shims that are received by thespacer 42.

Referring to FIGS. 17-26, the drive assembly 12 includes a first plungermember 52, a second plunger member 54 received by the first plungermember 52, a first biasing member 56, a second biasing member 58, aplunger actuation member 60, and an index member 62. The first plungermember 52 is moveable from a pre-use position (shown in FIG. 18), to ause position (shown in FIG. 19), to a post-use position (shown in FIG.20) with the first plunger member 52 configured to engage the spacerassembly 40 and move the stopper 34 within the container 14 to dispensemedicament from the container 14. The first plunger member 52 isconfigured to move axially. The second plunger member 54 and the firstplunger member 52 form a telescoping arrangement with the second plunger54 configured to move axially after the first plunger member 52 moves apredetermined axial distance. The movement of the first and secondplunger members 52, 54 is provided by the first and second biasingmembers 56, 58, which are compression springs, although other suitablearrangements for the biasing members 56, 58 may be utilized.

The first biasing member 56 is received by the second plunger member 54and is constrained between the plunger actuation member 60 (and indexmember 62) and a first spring seat 64 of the second plunger member 54.The second biasing member 58 is positioned radially inward from thefirst biasing member 56 and received by the second plunger member 54.The second biasing member 58 is constrained between a second spring seat66 of the second plunger member 54 and the first plunger member 52. Thesecond biasing member 58 is configured to bias the first plunger 52member towards the container 14 from the pre-use position, to the useposition, and to the post-use position. The first biasing member 56 isconfigured to bias the second plunger member 54 towards the container14, which, in turn, biases the first plunger member 52 towards thecontainer 14 from the pre-use position, to the use position, and to thepost-use position. More specifically, the second biasing member 58 isconfigured to drive the first plunger member 52 against the spacerassembly 40 or stopper 34 to move the container 14 into engagement thevalve assembly 16 thereby piercing the closure 36 of the container 14and placing the container 14 in fluid communication with the needle 28.The first biasing member 56 is configured to move the stopper 34 withinthe container 14 to dispense the medicament within the container 14. Thesecond biasing member 58 has a different spring constant than the firstbiasing member 56. In particular, the second biasing 58 member isstiffer than the first biasing member 56 to provide a high force forpiercing the closure 36 of the container 14 while the first biasingmember 56 provides a lower force for dispensing as appropriate for theviscosity of the fluid or medicament within the container 14.

Referring again to FIGS. 17-26, the plunger actuation member 60 has anannular portion 68 and a spindle portion 70. The plunger actuationmember 60 is rotationally moveable relative to the first plunger member52 between a first rotational position and a second rotational positionspaced from the first rotational position. The first rotational positionmay be 15 degrees from the second rotational position, although othersuitable positions may be utilized. The annular portion 68 includes adrive surface 72 including a plurality of gears 74, although othersuitable arrangements may be utilized for the drive surface 72. Thespindle portion 70 includes an actuator locking surface 76 configuredfor engagement and release from a plunger locking surface 78 of thefirst plunger member 52. The plunger locking surface 78 includes aplurality of projections 80 configured to be received by a plurality ofslots or cutouts 81 defined by the actuator locking surface 76.

As shown in FIGS. 18 and 23, in the first rotational position of theplunger actuation member 60, the plurality of projections 80 and theplurality of slots or cutouts 81 are out of alignment such that theplunger actuation member 80 is engaged with the first plunger member 52to prevent movement of the first and second plunger members 52, 54 withthe first and second biasing members 56, 58 biasing the first and secondplunger members 52, 54 away from the plunger actuation member 60. Asshown in FIGS. 19 and 24, in the second rotational position of theplunger actuation member 60, the plurality of projections 80 and theplurality of slots or cutouts 81 are aligned with each other such thatthe plunger actuation member 60 is disengaged with the first plungermember 52 to allow movement of the first and second plunger members 52,54 thereby starting the dispensing process from the container 14.

Referring to FIGS. 7 and 33, the drive surface 72 of the plungeractuation member 60 is configured to be engaged by a portion of theneedle actuator assembly 18. After engagement of the actuator button 26and release of the needle actuator assembly 18, which is discussed inmore detail below, the needle actuator assembly 18 moves within thehousing 20 from the pre-use position, to the use position, and to thepost-use position. During the initial movement of the needle actuatorassembly 18, a portion of the needle actuator assembly 18 engages thedrive surface 72 of the plunger actuation member 60 to move the plungeractuation member 60 from the first rotational position to the secondrotational position. As shown in FIG. 33, an angled blade portion 82 ofthe needle actuator assembly 18 engages the drive surface 72 of theplunger actuation member 60 to cause rotation of the plunger actuationmember 60.

Referring to FIGS. 11, 13, and 26, the second plunger member 52 includesa plurality of coded projections 84 with a preselected one of theplurality of coded projections 84 configured to engage a restrictionmember 86 of the system 10. As discussed in more detail below, therestriction member 86 cooperates with the needle actuation assembly 18and restricts movement of the needle actuator assembly 18 from the useposition to the post-use position until a predetermined end-of-doseposition of the stopper 34 is reached. In one aspect, the restrictionmember 86 is configured to restrict axial movement of the needleactuation assembly 18 from the use position through engagement betweenthe restriction member 86 and a portion of the needle actuation assembly18. Such engagement between the restriction member 86 and the needleactuation assembly 18 is released by rotation of the restriction member86 when the stopper 34 reaches the end-of-dose position. During the useposition of the needle actuator assembly 18, the restriction member 86is biased in a rotational direction with the rotation of the restrictionmember 86 being prevented through engagement between the restrictionmember 86 and one of the plurality of coded projections 84 of the secondplunger member 54. The plurality of coded projections 84 may be axialribs of varying length, although other suitable arrangements may beutilized. Each coded projection 84 defines a point at which therestriction member 86 is able to rotate thereby releasing the needleactuator assembly 18. The smooth portion of the second plunger member 52may also provide a further “code” for determining when the system 10transitions to the end-of-dose position.

As discussed above, the indicator arrangement 32 moves with differentportions of the indicator arrangement 32 visible through the indicatorwindow 30 as the system 10 moves from the pre-use, use, and post-use orend-of-dose positions. More specifically, the indicator arrangement 32engages a portion of the restriction member 86 and moves along with therestriction member 86 through the various stages of the system 10 toprovide an indication to the user regarding the state of the system 10.

During assembly of the system 10, the dosage of the container 14 ismatched with a specific spacer 42 having a set length and acorresponding one of the plurality of coded projections 84 is alignedwith the restriction member 86. Accordingly, as discussed above, thecontainer 14 may be provided with a plurality of dosage volumes witheach volume corresponding to a specific spacer 42 and coded projection84. Thus, even for different dosage volumes, the system 10 is configuredto inject the needle 28 into the user to deliver a dose of medicamentfrom the container 14, retract the needle 28 after the end of the dose,and provide an indication of the status of the system 10 whileminimizing abrupt engagement of the stopper 34 by the drive assembly 12.In particular, the size of the stopper 34 may be selected to minimizethe distance between the first plunger member 52 and the spacer assembly40 and does not require the use of damping.

Referring to FIGS. 27-33, a drive assembly 12A according to a furtheraspect of the present invention is shown. The drive assembly 12A shownin FIGS. 27-33 is similar to and operates in the same manner as thedrive assembly 12 shown in FIGS. 17-26 and described above. In the driveassembly of FIGS. 27-33, however, the first plunger member 52 isreceived by the second plunger member 54 and extends from the secondplunger member 54 during axial movement from the pre-use position to theuse position. Further, the first plunger member 52 includes an extensionportion 88 configured to engage the second plunger member 54 after thefirst plunger member 52 moves predetermined axial distance such that thefirst and second plunger members 52, 54 move together. The first andsecond biasing members 56, 58 engage and act on the first and secondplunger members 52, 54 in the same manner as the drive assembly 12 ofFIGS. 17-26.

Referring to FIGS. 27-32, the index member 62 is positioned about thefirst and second plunger members 52, 54 and includes a plurality ofratchet teeth 90 configured to engage a flexible tab 92 positioned onthe bottom portion 24 of the housing 20. When the drive assembly 12, 12Ais installed into the bottom portion 24 of the housing 20, theengagement of the ratchet teeth 90 of the index member 62 with theflexible tab 92 of the housing 20 provide a one-way rotation of theindex member 62. The index member 62 is configured to rotate to alignone of the coded projections 84 of the second plunger member 52 with therestriction member 86 based on the dosage volume and spacer 42 size asdiscussed above. The index member 62 may provide the drive assembly 12,12A with 24 rotational positions of which 12 may have unique dose valuesassociated with them.

Referring to FIGS. 1-16 and 34-40B, the needle actuator assembly 18according to one aspect of the present invention is shown. The needleactuator assembly 18 includes a needle actuator body 96 having guidesurfaces 98, a needle shuttle 102 having cam surfaces 104, and theneedle 28 received by the needle shuttle 102 and configured to be influid communication with the container 14 as discussed above. The needleactuator body 96 is generally rectangular with the guide surfaces 98protruding radially inward. The needle shuttle 102 is received withinthe needle actuator body 96. As described above, the needle actuatorbody 96 is moveable within the housing 20 from a pre-use position (shownin FIGS. 4-6), an initial actuation position (FIGS. 7-9), a use position(FIGS. 10-12), and a post-use position (FIGS. 13-15). The needleactuator body 96 is biased from the pre-use position to the post-useposition via an extension spring 106, although other suitable biasingarrangements may be utilized. The needle actuator body 96 is releasedand free to move from the pre-use position to the use position uponengagement of the actuator button 26, which is discussed in more detailbelow. The needle actuator body 96 moves from the use position to thepost-use position after rotation of the restriction member 86 asdiscussed above in connection with FIGS. 17-33.

Referring to FIGS. 34-40B, the needle shuttle 102 is moveable along avertical axis between a retracted position where the needle 28 ispositioned within the housing 20 and an extended position where at leasta portion of the needle 28 extends out of the housing 20. The needleshuttle 102 is configured to move between the retracted position and theextended position through engagement between the guide surfaces 98 ofthe needle actuator 96 and the cam surfaces 104 of the needle shuttle102. The cam surfaces 104 are provided by first and second cam members108, 110, with the first cam member 108 spaced from the second cammember 110. The housing 20 includes a guide post 112 having recessconfigured to receive a T-shaped projection 114 on the needle shuttle102, although other shapes and configurations may be utilized for theguide post 112 and T-shaped projection 114. The needle shuttle 102 movesalong the guide post 112 between the retracted and extended positions.The guide post 112 is linear and extends about perpendicular from thehousing 20, although other suitable arrangements may be utilized. Theguide surfaces 98 of the needle actuator body 86 are non-linear and eachinclude a first side 116 and a second side 118 positioned opposite fromthe first side 116.

As discussed below, the guide surfaces 98 of the needle actuator body 96cooperate with the cam members 108, 110 of the needle shuttle 102 tomove the needle shuttle 102 vertically between the retracted andextended positions as the needle actuator body 96 moves axially from thepre-use position to the post-use position. The needle shuttle 102 alsoincludes a shuttle biasing member 120 configured to engage the housing20 or the actuator button 26. In particular, the shuttle biasing member120 engages the housing 20 or actuator button 26 and provides a biasingforce when the needle actuator body 96 is transitioning from the useposition to the post-use position. When the needle actuator body 96 isfully transitioned to the post-use position, the cam members 108, 110 ofthe needle shuttle 102 are disengaged from the guide surfaces 98 of theneedle actuator body 96 and the shuttle biasing member 120 biases theneedle shuttle 102 downward such that the needle 28 engages the pad 38,as discussed above. As discussed above in connection with FIGS. 1-16,however, the pad 38 may also be biased into the needle 28 rather thanbiasing the needle shuttle 102 downwards via the shuttle biasing member120. The needle actuator body 96 may interact with the actuator button26 to prevent the actuator button 26 from popping back up until thepost-use position is reached, which is discussed below in more detail.

Referring to FIGS. 37A-40B, in a pre-use position (FIG. 37A), the needleshuttle 102 is in the retracted position with the cam members 108, 110spaced from the guide surface 98 of the needle actuator body 96. As theneedle actuator body 96 moves to the use position (FIGS. 37B and 38A),the second cam member 110 of the needle shuttle 102 engages the secondside 118 of the guide surfaces 98 to move the needle shuttle 102 fromthe retracted position to the extended position. During the transitionfrom the use position to the post-use position of the needle actuatorbody 96 (FIG. 37C), the first cam member 108 of the needle shuttle 102is engaged with the first side 116 of the guide surfaces 98 to move theneedle shuttle 102 from the second position to the first position. Afterthe needle actuator body 96 is fully transitioned to the post-useposition (FIGS. 37D and 38B), the shuttle biasing member 120 biases theneedle shuttle 102 downward as the cam members 108, 110 disengage fromthe guide surfaces 98 of the needle actuator body 96 with the needle 28engaging the pad 38. The transition of the needle actuator body 96 andthe corresponding position of the needle shuttle 102 is also shown inFIGS. 39-40B. The interaction between the actuator button 26 and theneedle actuator body 96 is discussed in detail in connection with FIGS.65A-67. Referring to FIGS. 41-64, a drug delivery system 200 accordingto a further embodiment is shown. The system 200 includes a housing 202having an upper housing 204 and a lower housing 206. The housing has aproximal end 205 and a distal end 207. The upper housing 204 has astatus view port 208 so that a user can view the operating status of thesystem 200. The system 200 also includes a valve assembly 212, a tube214 fluidly connecting the valve assembly 214 with a patient needle 215that is disposed in a proximal end of a needle arm 216. A spring 218biases a needle actuator 220 distally.

As shown in FIGS. 42-46, the system 200 additionally includes acontainer or medicament container 222 with a stopper 224 movablydisposed therein, although the stopper 224 is omitted from variousfigures to aid clarity. Preferably, the distal end of the medicamentcontainer 222 has a septum assembly 228 that is spaced apart from thevalve assembly 212 prior to actuation of the device 222, as best shownin FIG. 47.

For manufacturing purposes, using one size for a medicament container isoften desirable, even if multiple fill volumes or dosages arecontemplated for use with the container. In such cases, when medicamentcontainers are filled, the differing fill volumes result in differentpositions of the stopper. To accommodate such different stopperpositions, as well as accommodate manufacturing differences of thestoppers, aspects of the present invention include a bespoke or customspacer 226 disposed in a proximal end of the container 222, proximal tothe stopper 224. In other words, the bespoke spacer 226 provides anoption that allows dispensing of a range of manufacturer-set pre-definedfill volumes by selection of different spacers 226, and reduces oreliminates the need for assembly configuration operations. The size ofthe spacer 226 can be employed to account for under-filled volumes ofthe container 222, and provide a consistent bearing surface at theproximal end of the container.

The spacer 226 is selected from a plurality of different size spacers226 to occupy space from a proximal end of the stopper 224 to a proximalend of the container 222. According to one embodiment, as shown in FIGS.45-47, the spacer 226 is selected to be substantially flush with theproximal end of the container 222. Additionally, according to oneembodiment, the spacer 226 has a “top hat” shape, which includes acentral column 230 and a distal flange 232, as best shown in FIG. 45.

Returning to FIGS. 44-47, the system 200 also includes a drive assembly234 for displacing the container 222 distally to establish the fluidconnection between the container 222 and the patient needle 215, as wellas dispensing the medicament from the container 222. In more detail, thedrive assembly 234 includes an inner spring 236 disposed within acentral plunger 238, an outer plunger 240, an outer spring 242 disposedbetween the central plunger 238 and the outer plunger 240, a telescopingmember 244, and a release gate 246.

Preferably, the inner spring 236 has a greater spring constant than theouter spring 242, and is therefore, stronger or stiffer than the outerspring 242. The inner spring 236 is disposed inside the central plunger238, and pushes between a spring flange 248 in the lower housing (bestshown in FIG. 46) and the central plunger 238, which bears directly onthe proximal end of the spacer 226 subsequent to device activation. Theouter spring 242 is disposed inside outer plunger 240, and pushesbetween a proximal external flange 250 of the central plunger 238 and adistal internal flange 252 of the outer plunger 240. Thus, the inner andouter springs 236 and 242 are nested, and can provide a more compactdrive assembly (and thus, a more compact system 200) than employing asingle spring.

According to one aspect, the inner spring 236 acts only to displace thecontainer 222 to establish the fluid connection with the patient needle215, and the outer spring 242 acts only to subsequently dispense themedicament from the container 222. According to another aspect, theinner spring 236 acts to displace the container 222 to establish thefluid connection with the patient needle 215, and also acts to begindispensing the medicament from the container 222, and the outer spring242 acts to complete dispensing the medicament. In a further aspect, theinner spring 236 causes the initial piercing of the container 222 withthe outer spring 242 completing the piercing and dispensing of themedicament from the container 222.

As shown in FIGS. 44-47, and as subsequently described in greaterdetail, the outer plunger 240 includes a pair of proximal flanges orfeet 254 that each have a slanted surface that interacts with acorresponding slanted surface (or surfaces) on the release gate toretain and subsequently release the power module subsequent to actuationof the device 200.

As best shown in FIGS. 46 and 47, as initially assembled, the container222 is disposed in clearance from the drive assembly 234 and the valveassembly 212. A lateral flange 256 on the needle actuator 220 axiallyretains the medicament container 222, and the needle actuator 220prevents the release gate 246 from displacing laterally. According toone embodiment, a spring (not shown) biases the needle actuator 220distally, but the actuation button 210 (and/or its associated assembly)prevents distal displacement of the needle actuator 220 prior toactuation of the device 200. A status bar 258 is disposed on the needleactuator 220, and has a top surface that is visible through the statusview port 208. According to one embodiment, the top surface of thestatus bar has a plurality of colors or patterns, and when the device isin a pre-actuated state, a first color or pattern, such as yellow, isvisible through the status view port 208.

FIGS. 48-52 are top views of the system 200 illustrating the operationof events at and subsequent to actuation of the system 200. In FIG. 47,a user slides the actuation button 210 proximally and then displaces thebutton 210 vertically into the housing 202, thereby freeing the needleactuator 220 to displace distally under the influence of the spring(omitted for clarity). As shown in FIG. 49, as the needle actuatordisplaces distally, tracks 260 on the needle actuator 220 interact withlateral bosses 262 on the needle arm 216 to insert the patient needle215. Preferably at this stage, the proximal end of the needle actuator220 has not yet cleared the release gate 246, and thus, the driveassembly 234 has not yet been released. But the lateral flange 256 hasdisplaced distally and therefore, the container 222 is unrestrained.

Subsequently, as shown in FIGS. 50 and 51, with continued distaldisplacement, the proximal end of the needle actuator 220 clears therelease gate 246 (thereby releasing the drive assembly 234). The needleactuator 220 comes to temporarily rest against a feature on a rotatablerelease flipper 264, driving the release flipper 264 against anoutrigger 266 (best shown in FIGS. 44 and 59) of the telescoping member244. The needle actuator 220 remains in this position until themedicament has been dispensed. In this position, preferably, a secondcolor or pattern of the status bar 258, such as green, is visiblethrough the status view port 208.

At this stage, the force of the springs 236 and 242 and the interactionof the angled surfaces of the proximal flanges or feet 254 with thecorresponding angled surface (or surfaces) on the release gate 246causes the release gate 246 to displace laterally, thereby freeing theouter plunger 240 from restraining interaction with the release gate246. Up to this point, the outer plunger 240 has been restraining thecentral plunger 238.

Referring to FIGS. 52 and 53 (the inner spring 236 is omitted from FIG.52 for clarity), the stiff inner spring 236 distally drives centralplunger 238 to contact the spacer 226. Because the medicament container222 is filled with a substantially incompressible fluid, the continueddistal displacement of the central plunger 238 distally displaces thespacer 226, the stopper 224, and the container 222 relative to thehousing 202. This distal displacement causes the septum assembly 228 tobe pierced by the valve assembly 212, establishing fluid communicationbetween the container 222 and the patient needle 215. The centralplunger 238 travels distally until its proximal external flange 250(best shown in FIG. 59) contacts a flange on the lower housing 206,thereby limiting the “piercing travel.” Preferably, another flange onthe lower housing 206 and/or the lateral flange 256 of the needleactuator 220 limits distal travel of the container 222.

Subsequently, because the inner spring 236 can no longer distallydisplace the central plunger 238, the lighter outer spring 242 distallydisplaces the outer plunger 240 relative to the central plunger 238 tocontact the distal flange 232 of the spacer 226, as shown in FIGS. 54and 55. As subsequently described in greater detail, preferably, thecontact between the outer plunger 240 and the spacer 226 is damped tominimize the impact force. Further expansion of the outer spring 242distally displaces the outer plunger 240 to dispense the medicament.

As shown in FIGS. 56 and 57, as the outer spring 242 continues to expandand distally displace the outer plunger 240, upon a predetermined distaldisplacement of the outer plunger 240 relative to the telescoping member244, an external feature or flange 268 of the outer plunger 240interacts with an internal distal feature or flange 270 of thetelescoping member 244 to “pick up” the telescoping member 244. Thisensures that further distal displacement of the outer plunger 240 causescorresponding distal displacement of the telescoping member 244. Thispaired distal displacement continues until the end of the medicamentdispensing.

As previously noted, the outrigger 266 is disposed on the telescopingmember 244. The axial length of the outrigger and the distal travel ofthe telescoping member 144 controls the timing of the disengagement ofthe outrigger 266 with the release flipper 264. As shown in FIGS. 58 and59, at the end of medicament dispensing, the proximal end of theoutrigger 266 bypasses the release flipper 264. This allows the releaseflipper 264 to rotate out of engagement with the needle actuator 220(FIG. 60), and allows the needle actuator 220 to continue its distaldisplacement and withdraw the patient needle 215 (FIG. 61). At thisstage, another color or pattern of the status bar 258, such as red, isvisible through the status view port 208, signifying that the device 200has completed operation.

As previously noted, the contact between the outer plunger 240 and thespacer 226, as illustrated in FIGS. 62 and 63, is preferably damped tominimize the impact force. The highest level of energy dissipation isdesirable for under-filled syringes containing viscous fluid, as theouter spring 242 will be stiffer to provide desired dispense rates. Thelowest level of energy dissipation is desirable for maximum-filledsyringes containing low-viscosity fluid, as the outer spring can be lessstiff to provide desired dispense rates. Various methods can be employedto adjust damping levels, such as air damping, or closed-cell foamdamping.

As another method of damping the impact force, FIG. 64 illustrates anembodiment of a spacer 226 in which one or more axial interface ribs 272are circumferentially arrayed about the central column 230 of the spacer226. In this embodiment, the outer plunger 240 must drive past theinterference ribs 272, which provide frictional resistance to the distaldisplacement of the outer plunger 240 relative to the spacer 226. Thefrictional force created by the interference between interference ribs272 and the outer plunger 240 is independent of plunger speed.Preferably, the frictional force does not exceed the minimum dispensespring load, to avoid stalling weaker springs. The interference can betuned to give the desired level of frictional resistance. For differentfluid viscosities, there can be different sizing (axial and/or radial)of the interference ribs 272. This could mean a bespoke or custom spacerfor each viscosity and fill-level combination, or, depending on thenumber of springs required for a viscosity range, there can be a numberof tined positions, whereby the spacer can be set to a particularposition for a particular modular spring (the position have had theinterference/damping tuned for that particular spring load/viscosityscenario).

Referring to FIGS. 65A-69, an actuator button arrangement 280 foractuating the system 10 according to one aspect of the present inventionis shown. The actuator button arrangement 280 includes the actuatorbutton 26, a button spring 284, and a needle actuator body 286. Theneedle actuator body 286 may be similar to the needle actuator bodies96, 220 discussed above and configured to move within the housing 20 totransition the needle shuttle 102 or needle 28 between retracted andextended positions. As shown in FIG. 69, the actuator button 26 includesa user interface portion 288 for interacting with a user. Preferably,the user interface portion 288 is about 22 mm long and about 10 mm wide,although other suitable dimensions may be utilized. The actuator button26 includes two pairs of lockout arms 290, 292 that interact with buttoncontacting surfaces 294, 296 on the needle actuator body 286 prior todevice actuation to prevent the needle actuator body 286 from rockingupward. As shown in FIG. 65H, an overlap between the needle actuatorbody 286 and the housing 20 prevents premature actuation. Referring toFIG. 66, the button spring 284 includes a first bearing surface 298 anda second bearing surface 300 spaced from the first bearing surface 298,and a cantilevered central spring arm 302 surrounded by a pair of outerarms 304 that are joined by the first bearing surface 298.

The actuation button arrangement 280 is configured to provide one ormore of the following features, which are discussed in more detailbelow: one-way axial displacement or sliding of the actuator button 26;transverse movement (raised and depressed positions) of the actuatorbutton 26 where the actuator button 26 remains depressed during the useposition of the needle actuator body 286; and lockout of the actuatorbutton 26 in the post-use position of the needle actuator body 286 suchthat the button 26 is in the raised position and cannot be depressed bya user.

To actuate the system 10 using the actuator button 26, the user firstslides the user interface portion 288 in a first axial direction, shownas being to the right in FIGS. 65G and 65H. The user may be required toslide the user interface portion 288 about 10 mm or about 8 mm, althoughother suitable distances may be utilized. Moving the actuator button 26axially moves the lockout arms 290, 292 to clear the button contactsurfaces 294, 296 on the needle actuator body 286 to allow movement ofthe actuator button 26 from the raised position to the depressedposition.

As the user distally slides the user interface portion 288, the centralspring arm 302 of the button spring 284 rides over a spring arm 306bearing surface on the housing 20 while the first and second bearingsurfaces 298, 300 engage first and second bearing ramps 308, 310 on thehousing 20. The forces on the button spring 284 are balanced through theengagement with the spring arm bearing surface 306 and the first andsecond bearing ramps 308, 310 to provide a smooth axial displacement orsliding of the actuator button 26.

As the actuator button 26 and the button spring 284 reach the end oftheir axial sliding travel, the central spring arm 302 and the firstbearing surface 298 pass the end of a respective stops 312, 314 toprevent the actuator button 26 from sliding backward to its originalposition, as shown in FIG. 65H. Further, when the actuator button 26 andthe button spring 284 reach the end of their axial sliding travel, theuser engages the user interface portion 288 to move the actuator button26 downward to its depressed position. The actuator button 26 may bedepressed about 2 mm and the minimum force required to depress theactuator button 26 is about 3 N, and most preferably, about 2.8 N,although other suitable distances and minimum forces may be utilized.

As the user depresses the user interface portion 288, shown in FIGS. 65Aand 65B, the actuator button 26 rotates the needle actuator body 286 torelease the needle actuator body 286 thereby allowing the needleactuator body 286 to move from the pre-use position to the use position.As shown in FIG. 65B, as the needle actuator body 286 travels to the useposition, the lockout arms 290, 292 run along the underside of thebutton contact surfaces 294, 296 to prevent the actuator button 26springing upward. After the medicament has been delivered and as theneedle actuator body 286 is transitioning from the use position to thepost-use position, shown in FIG. 65C, the lockout arms 290, 292 aredisengaged from the button contact surfaces 294, 296 allowing theactuator button 26 to spring back up under the influence of the buttonspring 284. Once the needle actuator body 286 fully transitions to thepost-use position, shown in FIG. 65D, the actuator button 26 hasfinished moving from the depressed position to the raised position dueto the biasing force of the button spring 284. When the needle actuatorbody 286 is in the post-use position, a spring arm 316 on the needleactuator body 286 engages the actuator button 26 to prevent the actuatorbutton 26 from moving to the depressed position while axial movement isstill restricted by the engagement of the spring arm 302 with the stops312, 314. Thus, the actuator button 26 is locked after delivery of themedicament is complete to provide a clear indication between a usedsystem and an unused system.

Furthermore, if the user holds down the actuator button 26 duringdispensing of the medicament, proper dosing and needle retraction willstill complete, but the actuator button 26 will not spring back up tothe raised position until the button 26 is released.

In one aspect, the button spring 284 is made of plastic. The buttonspring 284 may also be a pressed metal spring could be used instead,although any other suitable material may be utilized.

Referring to FIGS. 68A-68G, rather than providing a separate actuatorbutton 26 and button spring 284, the spring may be provided integrallywith the button 26. More specifically, an actuator button 320 accordingto a further aspect of the present invention includes an integral springarm 322. The actuator button 320 also includes lockout arms 324,retention arms 326, and a rear pivot 328. As shown in FIGS. 68D and 68E,the spring arm 322 engages prongs 330 in the top portion 22 of thehousing 20. During transition of the system 10 from the pre-use positionto the use position, the spring arm 322 slides past a detent of theprongs 330 providing an axial spring force. The end of the spring arm322 engages a portion of the top portion 22 of the housing 20 to providethe vertical spring force as the spring arm 322 deflects. The actuatorbutton 320 is configured to a fluid motion between the sliding anddepression movements of the button 320 even though two separate motionsare occurring, which is similar to the operation of the button 26discussed above. During transition between the pre-use position and theuse position, the button 320 pivots about the rear pivot 328 with theretention arm 326 engaging a portion of the needle actuator body 286thereby maintaining a depressed position of the button 320 until theend-of-dose position is reached in a similar manner as actuator button26. The lockout arms 324 deflect inwards and engages a portion of theneedle actuator body 286 as the needle actuator body 286 moves to theend-of-dose position thereby preventing further movement of the actuatorbutton 320 in a similar manner as the actuator button 26 discussedabove.

Aspects of the present invention provide improvements over previousbutton designs. For example, the actuation button arrangement 280provides multiple surfaces to hold the needle actuator body 286 in placeagainst a needle actuator spring 106 prior to actuation, therebyreducing the likelihood of premature actuation during a drop impact. Theactuation button arrangement 280 physically prevents the needle actuatorbody 286 from moving prior to actuation by holding it in a tilted(locked) state in such a way that the surfaces have no room to separateand pre-activate.

In addition, button slide forces of the actuation button arrangement 280are controlled more precisely by utilizing a flexing arm rather thanusing a simple bump detent. This permits longer sliding strokes of thebutton 26 with better force control, resulting in a more ergonomicallyeffective design. Further, the actuation button arrangement 280 causesthe button 26 to pop back out at the end of injection, giving the useran additional visual, audible, and tactile indication that themedicament delivery is completed.

According to one aspect, the fluid delivery volume of the system 10 isdetermined by the end position of a plunger relative to a point insidethe housing regardless of actual fill volume, container inner diameter,and stopper starting position and length. The dosing accuracyvariability can be significant because the tolerances of the factorsabove can be quite large. Aspects of the present invention allow for theelimination of some or all of these tolerances from the dosing equation,resulting in a more precise and less variable injection volume ofmedicament.

Referring to FIGS. 70A-70G, a spacer assembly 400 for use in connectionwith a drive assembly according to one aspect of the present inventionis shown.

Elements in a chain of tolerances in the stopper spacer assembly 400include a thickness (A) of a flange 402 of an inner plunger 404, aninternal length (B) of an outer plunger 406 between an internal proximalend 408 and an internal shoulder 410, and an initial offset distance(C₁) between the inner plunger flange 402 and the internal proximal end408 of the outer plunger. This initial offset distance (C₁) ispreferably greater than a gap distance (C₂) between outer plunger 406and the proximal end of the medicament barrel 412. The chain oftolerances in the stopper spacer assembly 400 also includes the internalbarrel diameter (D). Once assembled, the stopper spacer 414 and theouter plunger 406 are unique for a given medicament volume.

FIGS. 70B-70G illustrate operation of the stopper spacer assembly 400.As shown in FIG. 70B, when the system is actuated, the both inner andouter plungers 404 and 406 are released. An outer spring 416 pushes theouter plunger 406 into the barrel 412, compressing damping material 418,and an inner spring 420. The stopper 422 does not yet mover relative tothe barrel 412 due to the fluid column of medicament.

Next, as shown in FIG. 70C, the outer spring 416 distally displaces theouter plunger 406 and the barrel 412 to open a valve (not shown) at thedistal end of the barrel 412 that establishes fluid communication withthe needle (not shown). Due to the incompressibility of the liquidmedicament, the stopper 422 cannot displace relative to the barrel 412until the valve is opened and the fluid path to the patient needle isestablished.

Subsequently, as shown in FIGS. 70D and 70E, the inner spring 420displaces the inner plunger 404, the stopper spacer 414, and the stopper422, to dispense the fluid.

FIG. 70F illustrates the end of medicament delivery when the proximalflange 402 of the inner plunger 404 contacts the internal shoulder 410of the outer plunger 406, thereby ceasing displacement of the innerplunger 404 (and the stopper spacer 414 and stopper 422) relative to themedicament barrel 212 and stopping the flow of medicament.

According to one aspect, as shown in FIG. 70G, the cessation ofdisplacement of the inner plunger 404 relative to the medicament barrel412 triggers an end-of-dose indicator for the system.

Referring to FIGS. 71 and 72, a collapsible spacer assembly 430 includesa forward spacer portion 432 secured to a stopper 434, an inner plunger436, a rear spacer portion 438, and a rotating shuttle 440. The innerplunger 436 can translate relative to the forward spacer portion 432,but not rotate relative thereto. Similarly, the rear spacer portion 438can also move axially relative to the forward spacer portion 432, butnot rotate relative to the forward spacer portion 432. As subsequentlydescribed in greater detail, the rotating shuttle 440 first rotates, andsubsequently translates.

According to one aspect, forward spacer portion 432 is fixedly securedto the stopper 434. One skilled in the art will understand that manymethods can be employed to secure the forward spacer portion 432 to thestopper 434, for example, adhesive, mechanical fasteners, or any othersuitable arrangement. Preferably, the forward spacer portion 432includes threads that engage mating threads in the stopper 434.

When the stopper spacer assembly 430 is screwed into the stopper 434, anaxial load is applied through access openings 442 in the rear spacerportion 438. This force can be used to push the stopper 434 forward,applying pressure to the fluid medicament. This pressure causes thefront (distal) face of the stopper 434 to deflect and press proximally,pushing back on the rear spacer portion 438 and rotating the rotatingshuttle into its “as assembled” condition. In other words, when amedicament barrel is filled with medicament and the system's plunger isapplying axial force to the medicament via the spacer assembly 430, thedistal face of the stopper 434 is deformed by the pressure of themedicament. During medicament delivery, pressure is applied by a driveassembly (via the plunger) to the rear spacer portion 438, which in turnapplies a rotational torque to the rotating shuttle 440 via helicalfaces 444 of the rear spacer portion 438. But the stopper deformationfrom the medicament provides a rearward or proximal force on the innerplunger 436, which prevents rotation of the rotating shuttle 440.

According to one aspect, an axial reaction load on the inner plunger 436can be increased by increasing the length of the inner plunger 436.

Once the medicament delivery is complete, as shown in FIG. 73, thepressure on the stopper 434 decreases, thereby permitting the distal endof the inner plunger 436 to displace distally. This distal displacementpermits the rotating shuttle 440 to rotate. The continued axial forceapplied by the drive assembly rotates and distally displaces therotating shuttle 440 due to interaction of the helical faces 444 in therear spacer portion 438 with corresponding cam-faced arms 446 of therotating shuttle 440. According to one aspect, this final movement ofthe rotating shuttle 440 causes the drive assembly to trigger needleretraction.

Referring to FIGS. 74 and 75, a restriction member 452 according to oneaspect of the present invention is disposed with the drive assembly. Therestriction member 452 governs the timing of the final displacement ofthe needle actuator bodies 96, 220 subsequent to the completion of themedicament dose. Instead of rotating about a fixed post, the restrictionmember 452 floats freely. Once a plunger displaces sufficiently distallyfor a gap to align with the restriction member 452 (as shown in FIGS. 74and 75), the restriction member 452 displaces laterally into the gapbecause of the force of the spring on the needle actuator 96, 220 andthe angled face 454 on the rear of the arm of the restriction member 174that engages the needle actuator body (best shown in FIG. 75). Once therestriction member no longer retains the needle actuator body 96, 220,the needle actuator body 96, 220 is free to complete the axial movementto the post-use position. Further, as shown in FIG. 75, the restrictionmember 452 is biased onto the rear of the barrel portion of thecontainer 14, which minimizes the tolerance chain of the variouscomponents and improves dose accuracy.

Referring to FIGS. 76-78, a spacer assembly 460 according to a furtheraspect of the present invention is shown. The spacer assembly 460 shownin FIGS. 76-78 allows for the removal of the effect of manufacturingtolerance build up through adjustment of the spacer assembly therebyallowing each system to inject the same amount of medicament.

As shown in FIG. 77, the spacer assembly 460 includes a stopper 462 anda stopper spacer 464. The stopper spacer 464 includes a fixed spacerpiece or fixed spacer 466 that is fixedly connected with the stopper462, and an adjustable spacer piece or adjustable spacer 468 that isrotationally displaceable in one direction relative to the fixed spacer466.

One skilled in the art will understand that many methods can be employedto secure the fixed spacer 466 to the stopper 462, for example,adhesive, mechanical fasteners, or any other suitable arrangement.Preferably, the fixed spacer 466 includes one or more external threadsthat engage one or more mating threads in the stopper 462. According toone aspect, the adjustable spacer 468 has a distal stem with an externalthread 470. The distal stem thread 470 engages an internal thread 472 inthe fixed spacer 466 (best shown in FIG. 78) to rotationally controlaxial displacement of the adjustable spacer 468 relative to the fixedspacer 466.

As shown in FIGS. 76 and 77, the fixed spacer 466 includes radiallyspaced detents 474 and the adjustable spacer 468 includes a springdetent arm 476, the free end of which engages a selected one of thedetents 474 to prevent rotation and axial displacement of the adjustablespacer 468 toward the fixed spacer 466. The free end of the springdetent arm 476 is shaped to pass over the detents 474 in one direction,thereby permitting rotation and proximal axial displacement of theadjustable spacer 468 away from the fixed spacer 466.

Despite variations in the dimensions of stoppers and containers, theadjustable spacer 468 can be adjusted relative to the fixed spacer 466to provide a consistent axial length of the stopper assembly 460.

As shown in FIG. 78, once the container is filled, an axial load, suchas a load that would be encountered when installed in the system 10,200, can be applied to the adjustable spacer 468 (and thus, the fixedspacer 466 and the stopper 462). Once the axial load is applied, theadjustable spacer 468 can be proximally backed out to ensure aconsistent gap 478 between the proximal end of a medicament barrel 480and the proximal face of the adjustable spacer 468, thereby accountingfor variations in the medicament barrel glass and the compressibility ofany entrapped air. In other words, the spacer assembly 460 allows theadjustable spacer 468 to have a predetermined set position relative tothe container 14 independent of the variables of the container 14 andstopper length. Accordingly, the start position of the spacer assembly460 is a predetermined distance from the container 14 and the endposition of the spacer assembly 460 is also a predetermined distancefrom the container 14 such that the travel of the stopper 462 is definedby the effective length of the plungers 52, 54 of the drive assembly 12.

Referring to FIGS. 79 and 80, a base column 482 and a cap 484 of anautomatically adjusting spacer 486 according to one aspect of thepresent invention is shown. The base column 482 includes a base portion488 and an axially extending column 490. According to one embodiment,the base column 482 includes a plurality of columnar protrusions 491that each have a plurality of ratchet teeth 492 disposed on a proximalportion thereof. A locking barb 493 is disposed at the proximal end ofeach of the plurality of ratchet teeth 492. The cap 484 is hollow, and adistal end of the cap 484 includes one or more axial springs 494.According to one aspect, the axial springs 494 are bent, cantileveredarms formed during molding of the cap 484. According to another aspect,a separate biasing member, such as a compression spring can be employedin the automatically adjusting spacer 486. When assembled with the basecolumn 482, the springs 494 engage the base portion 488 and maintain aninitial spacing between the base column 482 and the cap 484. Accordingto one aspect, the springs 494 are omitted. The cap 484 also includes aplurality of flexible cantilevered arms or tabs 496, which each have afree proximal portion with a plurality internal of ratchet teeth 497.The proximal end of each flexible tab 496 includes a foot 498.

FIG. 81B illustrates the cap of the automatically adjusting spacerdeployed within a proximal recess of a stopper 494 at a proximal portionof a medicament barrel. The base column 482 is assembled into the hollowcap 484 with the base portion 482 engaging the stopper 494 and the feet498 disposed outside the proximal end of the barrel.

In operation, as shown in FIGS. 81A and 81B, the cap 484 displacesdistally relative to the base column 482 (as well as the stopper 494 andthe barrel) until the proximal end of the cap 484 is flush with the endof the medicament barrel. This action causes the feet 498 to engage theinternal surface of the barrel and displace radially inward, therebyforcing the ratchet teeth 492 into locking engagement with the ratchetteeth 497. The locking barb 493, the engagement of the ratchet teeth 492and 497, and the engagement of the feet 498 with the internal surface ofthe barrel prevents the displacement of the cap 484 relative to the basecolumn 482. Thus, the automatically adjusting spacer 486 can accommodatedifferences in stoppers, barrel diameters, and medicament fill volumes,to automatically provide a bearing surface flush the proximal end of themedicament barrel.

One aspect of the present invention is a spacer assembly 486 that issituated against the stopper in the container within the system. Thespacer design is such that its effective length can be adjusted in orderto allow the dispensing of a precise quantity of medicament. The lengthadjustment is intended to compensate for manufacturing tolerances withinthe container, the fill volume, and especially the stopper length, whichcan add up to ⅓ of the variability in a delivered dose using anon-adjustable spacer. The spacer length can be adjusted through severaltechniques, depending on the specific aspect. The spacer length can beself adjusting based on its location to the back of the container, itcan be adjusted by assembly equipment at the time of final assembly ofthe primary container into the subassembly, and it can be made anintegral part of the stopper and adjusted as a subassembly prior tofilling. The adjustable spacer 486 allows a more precise volume of fluidto be injected compared to a non-adjustable stopper.

Referring to FIGS. 82-87, a drive assembly 500 for a drug deliverysystem according to one aspect of the present invention is shown. Thedrive assembly 500 includes an actuation button 506, a container 508, aneedle actuator assembly 510, an actuation release or flipper 512, alead screw 514, and a plunger 516. The lead screw includes a drumportion 518 with external radially-protruding vanes 520, and, as bestshown in FIGS. 84 and 85 and subsequently described in greater detail, ascrew thread portion 522. Prior to activation, as best shown in FIGS. 83and 86 one end 513 of the actuation release 512 engages one of the vanes520 to prevent rotation of the lead screw 514.

According to one aspect, as shown in FIGS. 84-86, the screw threadportion 522 of the lead screw 514 engages internal threads of a nut 524connected with the plunger 516. According to another aspect, the nut andits internal threads are integrally formed with the plunger as a unitarystructure. Additionally, a constant force spring 526 is received withinthe drum portion 518 and biases the lead screw 514 in a rotationaldirection. According to one aspect, the spring 526 is secured to thebase cover 504. According to another aspect, as shown in FIGS. 84-86, adrive assembly housing 528 is disposed within the system and the spring526 is secured to the power pack housing 528.

Unlike a helical spring, such as a compression spring, which has a forceprofile proportional to its displacement, the constant force spring 526and the like maintain a relatively flat or even force profile over along working length. The even force profile advantageously provides aninjection force that is proportional to the spring force. This willprovide a flat or even injection force, and thus, a substantiallyconstant injection rate for the medicament. Although the spring 526 isillustrated in FIG. 86 as having only two turns of material, one skilledin the art will appreciate that fewer or greater numbers of turns can beemployed. Preferably, an assembler winds the spring 526 when the driveassembly 500 is assembled, and the spring 526 is stored in the woundposition until the time of actuation.

Upon actuation of the system, the needle actuator assembly 510 isreleased to axially displace (to the right in FIGS. 82-85) from thepre-use position to the post-use position under the influence of abiasing member 530 (best shown in FIG. 83). During this displacement,the needle actuator assembly 510 bears against a second end 532 of theactuation release 512 and rotates the release 512 counter-clockwise, asshown in FIG. 87. This counter-clockwise rotation of the actuationrelease 512 frees the first end 513 thereof from engagement with thevane 520. Subsequent to the disengagement of the first end 513 from thevane 520, the spring 526 unwinds and drives rotation of the lead screw514, which, in combination with the nut 524, advances the plunger 514 todispense the medicament.

As the lead screw 514 is rotating, the rotation of the drum portion 518and the vanes 520 is visible through a window 534 in the housing. Thiswindow 534 indicates progress of the screw in a way that is much moreapparent than viewing the linear movement of the stopper 536 in thecontainer 508. In fact, this rotational movement is many times moresensitive than the linear movement. One skilled in the art willappreciate that the exact amount of advantage or increase depends on thepitch of screw thread portion 522 of the lead screw 514, the diameter ofthe drum portion 518, and number of vanes 520 on the drum portion 518.

Referring to FIGS. 88-93, a drive assembly 600 for a drug deliverysystem according to a further aspect of the present invention is shown.The drive assembly 600 acts to store a spring's mechanical energy and toactivate it when triggered. The drive assembly 600 includes a medicamentbarrel 601, a stopper 602 slidably disposed in the barrel 601, a firstvalve plunger 603, a second valve plunger 604, a first revolve nut 605,and a second revolve nut 606. The drive assembly 600 also includes arotary indicator 607, a locking element 608, a constant force spring 609disposed within the rotary indicator 607, and an actuation release orflipper 610. The drive assembly 600 is at least partially disposedwithin a housing 611 that can be assembled into a drug delivery system.

The constant force spring 609 is contained between the housing 611 andthe rotary indicator 607 within a drum portion 616 of the rotaryindicator 607. The drive assembly's inactive state is such that energyis applied by uncoiling the spring 609 and harnessing this energygeometrically with the housing 611, rotary indicator 607, and actuationrelease 610. When the drive assembly 600 is deactivated, the springrecoils and translates the mechanical energy into rotational motion ofthe rotary indicator.

The telescoping multi-part plunger is oriented along a force axisbetween the medicament barrel 601 and the rotary indicator 607. Therotary indicator 607 features a threaded shaft 618. According to oneaspect, the threads are dual lead, and are either square or rectangularin nature. The multi-part telescoping plunger includes a two-partthreaded nut (first revolve nut 605 and second revolve nut 606) and atwo-part plunger (first valve plunger 603 and second valve plunger 604).The second revolve nut 606 is a threaded shaft that mates with therotary indicator 607 and first revolve nut 605 and features matchingthreads on its inner and outer surfaces (internal and external threads,respectively) to mate with them. The second revolve nut 606 also has acircular collar 620 (best shown in FIG. 92) on its proximal end thatbottoms down on the second valve plunger 604. The second revolve nut 606is free to spin along the force axis. The first revolve nut 605 is alsoa threaded shaft that features threads on its inner diametercorresponding to the external threads of the second revolve nut 606 tomate with the second revolve nut 606.

According to one aspect, on one end, the first revolve nut 605 has ahexagonal collar that press fits on the first valve plunger 603 tofixedly connect the first valve plunger 603 with the first revolve nut605. In the drive assembly 600, the first revolve nut is not free torotate and will only translate when the power module subassembly isactuated.

The second valve plunger 604 is a hollow cylindrical component with asmall collar 622 on its distal end, a large collar 624 on its proximalend, and an extended L-shaped arm 626 (best shown in FIG. 93) protrudingfrom the large proximal collar 624. According to one embodiment, thesmall collar 622 is discontinuous and features four leaf cantileveredarms or leaf springs 623 that allow the collar to bend and mate with thefirst valve plunger 603. The inner surface of the second valve plunger604 has an undercut through its length terminating at its proximal end aradially inward protruding shelf 628 of the large collar 624. The shelf628 engages the second revolve nut 606 within the telescoping assembly.

The first valve plunger 603 attaches to the stopper 602 and is also ahollow cylindrical component that mates with the second valve plunger604. More specifically, the first valve plunger 603 features acylindrical protrusion 630 on its distal end to mate with the stopper602. According to one aspect, as best shown in FIG. 89, four thru slots632 are disposed on the proximal quadrants of the first valve plunger603 to mate with the leaf springs or arms 623 and small collar portion622 of the second valve plunger 604. Both the first and second valveplungers 603 and 604 are free to slide.

Telescoping is achieved when the constant force spring 609 recoils andthe rotary indicator 607 starts spinning. The threaded attachmentbetween the rotary indicator 607 and the second revolve nut 606 causessecond revolve nut 606 to rotate. But because the second revolve nut 606is threaded to the first revolve nut 605, which cannot rotate andexperiences resistance to distal translation due to the pressure causedby medicament in the barrel 601, the second revolve nut 606 willdisplace proximally and bottom out on the second valve plunger'sradially inward protruding shelf 628. The second valve plunger 604 isprevented from displacing proximally by the housing 611. Subsequently,and with continued rotation of the rotary indicator 607, because thesecond revolve nut 606 is threaded with the first revolve nut 605 (whichcannot rotate) the first revolve nut 605 translates distally to push thefirst valve plunger 603 (and the stopper 602) to dispense medicamentfrom the barrel 601.

The first valve plunger 603 displaces distally relative to the secondvalve plunger 604 until the small collar sections 622 (respectivelydisposed on the distal ends of the leaf springs or arms 623 of thesecond valve plunger 604) engage the corresponding proximal ends of theslots 632 of the first valve plunger 603. This locks the relativeposition of the first and second valve plungers 603 and 604, withcontinued rotation of the rotary indicator 607, both valve plungerstranslate distally while also pushing the second revolve nut along(because of its proximal engagement with the shelf 624).

The initial and final positions of the telescoping plunger, and thus themedicament dose, are controlled by the rectangular thread form of thethreaded shaft 618 of the rotary indicator 607, a threaded shaft on thedrum portion 616 of the rotary indicator 607, and a stepped pin thatacts as the locking element 608. According to one aspect, threaded shafton the drum portion 616 of the rotary indicator 607 is single lead, andbecause the rest of the components in the telescoping chain have duallead threads, the axial travel of the other threaded components is twicethe axial travel of the lock 608 relative to the rotary indicator.

According to one embodiment, the lock 608 is cylindrical and features adomed tip on one end and a cylindrical collar on the other. The threadson the exterior of the rotary indicator's drum portion 616 along with aslot and undercut 636 at the bottom of the housing 611 captures the lock608 in place, allowing it to slide parallel to the force axis. Thus, asthe spring 609 is released and the rotary indicator 607 turns, the lock608 translates as well and creates a positive stop when the distal endof the thread on the exterior of the rotary indicator's drum portion 616is reached.

One benefit of aspects of the drive assembly 600 include the use of aconstant force spring 609, the mechanical energy of which is convertedinto substantially constant linear force to the medicament in the barrel601. In turn, this creates a uniform medicament delivery rate. Anotherbenefit is that employing the telescoping plunger driven by a threadform, the drive assembly can create in-line space savings of up to 0.75inches compared to other plunger designs. Additionally, the driveassembly provides a controlled medicament dose through an initial andfinal mechanical constraint within the same component.

As previously noted, other drug delivery systems utilize a compressedcoil spring, which exerts a maximum force at actuation that eventuallydecreases as the spring expands. A decreasing force at the plungertranslates into variable medicament delivery time and medicament exitpressure. By using a constant force spring, the force exerted on theplunger is constant from the beginning to the end of the dosage. Inaddition, the distance a coil spring has to travel in addition to thelength of a static plunger that needs translate inside the drugcontainer can create a long assembly. In contrast, in embodiments of thepresent invention, the constant force spring is contained radially anddoes not require any additional space before or after activation.Furthermore, the aspects of the telescoping plunger allow that theplunger length of the can be significantly reduced in comparison to thelength of a static plunger.

Previous drug delivery systems have variable dose accuracy performancebecause the mechanical components enabling the drug delivery create ageometric dependence by bottoming down on the container, which cannot befabricated with tight tolerances. Some embodiments of the presentinvention create a control to the start and end times of the translatingplunger via a thread form in the rotary indicator and the use of theconstant force spring.

The drive assembly creates a space saving geometry in addition towell-controlled time, volume and pressure for the drug delivery device,which translates to a more attractively compact and precise drugdelivery device.

Some aspects of the drive assembly implement three rotating threadedshafts to create a linear space savings of about 0.75 inch. In otheraspects, the same concept can be employed using two rotating threadedshafts and result in a space savings of about 0.5 inch. Some aspects ofthe present invention convert the rotational energy of a constant forcespring to a translational force motion of a plunger.

Referring to FIGS. 94-100, a spacer assembly 660 according to a furtheraspect of the present invention is shown. The spacer assembly 660 issimilar to the spacer assembly 460 discussed above and shown in FIGS.76-78 and operates in a similar manner to achieve similar advantages.The spacer assembly 660 includes a fixed spacer 666 and an adjustablespacer 668. The fixed spacer 666 is configured to be received by thestopper 462 with lugs 670 engaging the stopper 462 to secure the fixedspacer 666 within the stopper 462, although other suitable securingarrangements, such as threads, may be utilized. The fixed spacer 666includes interior threads 672 that receive exterior threads 678 of theadjustable spacer 668. The fixed spacer 666 includes a plurality ofdetents 674 positioned on a helical portion of the fixed spacer 666. Theadjustable spacer 668 includes a spring detent arm 676 that engages oneof the detents 674 to prevent rotation and axial displacement of theadjustable spacer 668 relative toward the fixed spacer 666. The springdetent arm 676 is shaped and configured to pass over the detents 674 inone direction to allow rotation and axial displacement of the adjustablespacer 668 away from the fixed spacer 666. The adjustable spacer 668 maybe initially secured to the fixed spacer 666 via the threads 672, 678 byapplying a force to the top of the spring detent arm 676, which biasesthe spring detent arm 676 away from the detents 674 to allow the spacers666, 668 to be secured to each other. Accordingly, in the same manner asdiscussed above in connection with spacer assembly 460, the adjustablespacer is free to rotate in one axial direction to adjust the length ofthe spacer assembly 660.

Referring again to FIGS. 94-100, the spacer assembly 660 furtherincludes a shim 680 configured to be received and secured to theadjustable spacer 668. Rather than providing a plurality of sizes ofadjustable spacers 468, 668, a plurality of shim 680 sizes can beprovided to accommodate a plurality of different fill volumes within thecontainer 14. The shim 680 may be secured to the adjustable spacer 668via a connector 682 extending from the shim 680 that is received by theadjustable spacer 668 using a snap-fit, although other suitable securingarrangements may be utilized. A center portion 684 of the fixed spacer666 is configured to be engaged while the adjustable spacer 668 isrotated relative to the fixed spacer 666 to prevent rotation of thefixed spacer 666 along with the adjustable spacer 268. The centerportion 684 of the fixed spacer 666 is accessible through an opening inthe shim 680.

Elements of one disclosed aspect can be combined with elements of one ormore other disclosed aspects to form different combinations, all ofwhich are considered to be within the scope of the present invention.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A spacer assembly for a drug delivery system forinjecting a medicament, the assembly comprising: a first spacer portionconfigured to be received by a stopper; a second spacer portion spacedfrom the first spacer portion a predetermined distance; an innerplunger; and a spacer shuttle received by the inner plunger, the innerplunger, the spacer shuttle, and the second portion of the spacerconfigured to move relative to the first spacer portion, whereinmovement of the second spacer portion is restricted by the spacershuttle, and movement of the spacer shuttle is restricted by the innerplunger.
 2. The assembly of claim 1, wherein the second spacer portionengages the spacer shuttle and is structured to move independently withrespect thereto.
 3. The assembly of claim 1, wherein the inner plungerhas a first position and a second position spaced axially from the firstposition, the spacer shuttle restricted from axial movement when theinner plunger is in the first position and moveable relative to thestopper when the inner plunger is in the second position.
 4. Theassembly of claim 3, wherein the second spacer portion is restrictedfrom axial movement via the spacer shuttle when the inner plunger is inthe first position and moveable relative to the stopper when the innerplunger is in the second position.
 5. The assembly of claim 3, whereinthe second portion of the spacer assembly is free to move toward thefirst portion of the spacer assembly when the first plunger is in thesecond position.
 6. The assembly of claim 1, wherein the spacer shuttleis rotatable relative to the inner plunger, and wherein axialdisplacement of the second portion of the spacer assembly is configuredto cause rotation of the spacer shuttle.
 7. The assembly of claim 6,wherein the second spacer portion of the spacer assembly defines anaccess opening configured to allow direct engagement of the first spacerportion of the spacer assembly.
 8. The assembly of claim 1, wherein thefirst portion of the spacer assembly and the second portion of thespacer assembly are secured to each other while allowing relative axialmovement for the predetermined distance.
 9. A drug delivery system forinjecting a medicament, the system comprising: a container configured toreceive a medicament, the container comprising a stopper and a closure,the stopper configured to move within the container from a pre-useposition to a post-use position; and a spacer assembly comprising afixed spacer and an adjustable spacer, the fixed spacer received by thestopper, the adjustable spacer secured to the fixed spacer and moveablerelative to the spacer assembly a predetermined axial distance.
 10. Thesystem of claim 9, wherein the adjustable spacer is only moveable in afirst axial direction relative to the fixed spacer.
 11. The system ofclaim 10, wherein the spacer assembly comprises a ratchet arrangementwith one of the fixed spacer and the adjustable spacer including aplurality of detents and the other of the fixed spacer and theadjustable spacer including a spring detent arm, and wherein rotation ofthe adjustable spacer relative to the fixed spacer in a first rotationaldirection moves the adjustable spacer the predetermined axial distance.12. The system of claim 11, further comprising a shim configured to besecured to the adjustable spacer.
 13. A drug delivery system forinjecting a medicament, the system comprising: a container configured toreceive a medicament, the container comprising a stopper configured tomove within the container and a closure; a drive assembly comprising: aplunger member configured to move the stopper within the container, theplunger member having a first position and a second position axiallyspaced from the first position; a biasing member configured to move theplunger member from the first position to the second position; and aplunger actuation member moveable relative to the plunger member, theplunger actuation member having a first position where the plungermember is axially fixed relative to the plunger actuation member and asecond position where the plunger member is axially moveable relative tothe plunger actuation member; a needle actuator assembly comprising aneedle configured to be placed in fluid communication with thecontainer, the needle moveable from a first position and a secondposition spaced from the first position; a restriction member configuredto restrict movement of the needle actuator assembly; and a spacerassembly comprising a fixed spacer and an adjustable spacer, the fixedspacer received by the stopper, the adjustable spacer secured to thefixed spacer and moveable relative to the spacer assembly apredetermined axial distance.
 14. The system of claim 13, wherein thespacer assembly further comprises an inner plunger and a spacer shuttlereceived by the inner plunger, and wherein the adjustable spacer engagesthe spacer shuttle and is structured to move independently with respectthereto when the plunger member moves between the first position and thesecond position.
 15. The system of claim 13, wherein the restrictionmember is configured to engage a rear portion of the container.